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Efficacy
of hydrolytic enzymes in preventing radiation therapy-induced side effects in
patients with head and neck cancers
Gujral
MS, Patnaik PM, Kaul R, Parikh HK, Conradt C, Tamhankar CP, Daftary GV
SGPT
Cancer Hospital, Indore, India
Purpose.
Based on in vitro and on clinical evidence of protection against acute side
effects of radiation, a prospective randomized, open study was performed to
determine the efficacy of an oral proteolytic enzyme preparation in patients
with head and neck cancer receiving conventional fractionated radiation therapy.
Methods.
Patients with stage T3/T4 head and neck cancer were eligible.
One hundred patients from two centres were entered into the study.
60Co gamma-radiation was delivered at a standard daily radiation dose of 2 Gy in
25-35 fractions over a period of 6-7 weeks.
Two lateral parallel opposing fields were used with a portal area of 10 x 15 cm.
Patients assigned to the test group arm additionally received enzyme tablets
orally t.i.d. starting 3 days prior to radiation therapy, and continuing up to 5
days after completion of the course of radiation therapy.
Patients in the control arm were not given any drug or placebo.
Acute radiation side effects were described as mucositis, skin reaction,
dysphagia, and were graded at each visit during and after radiation therapy,
following RTOG/EORTC criteria.
Results.
The severity (maximum extent) of acute radiation therapy side effects was
significantly less in enzyme-treated patients than in control patients:
mucositis (mean: 1.3 vs 2.2, P < 0.001), skin reaction (1.2 vs 2.4, P <
0.001) and dysphagia (1.4 vs 2.2, P < 0.001).
The duration of these side effects as well as the sum scores of side effects
were also less in the study arm.
Conclusions.
Combination of enzyme therapy with conventional fractionated radiation therapy
was feasible and well-tolerated.
There was significant protection against acute side effects of radiation therapy
in the study arm.
Not only was the severity of acute side effects less but the duration was
shorter and the time to onset was also delayed.
Prospective randomized double-blind studies would verify this role of an oral
enzyme therapy as standard co-medication with radiation therapy to the head and
neck region.
PMID:
11561868 [PubMed - indexed for MEDLINE]
Source:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11561868&dopt=Abstract
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